Nonconforming Product Problems in Medical Devices - Webinar CD/Transcript
Every medical device manufacturer has to deal with nonconforming product — but based on the number of warning letters citing 21 CFR 820.90, it’s clear many don’t know how.
Order Today — Avoid crucial regulatory mistakes.
Yes, mistakes happen. It’s human nature. So be smart, be preemptive. When finished device products — or in-process devices, device components, returned devices or specific manufacturing materials — don’t measure up, learn how to deal with them in ways that save money and keep the FDA off your corporate back.
This CD and transcript set will help you:
- Understand best practices for managing nonconforming product.
- Discover the crucial differences between a correction and a corrective action.
- Properly document decisions to use nonconforming product, using FDA-tested examples.
- Understand the need for retesting and reevaluation after rework.
- Know the role of quality data trending using appropriate statistical techniques in 820.100 and how this applies to nonconforming product.
- Reduce the chance that a nonconforming product investigation will lead to corrective action.
- Explain to FDA investigators why you were justified in using a nonconforming product for another use.
Order Now — Avoid Crucial Regulatory Mistakes